# K101709: Lambergsleepwell- Smartrusion (LSW-S)

- Pathway: 510(k) (Abbreviated)
- Applicant: Steven B. Lamberg, Dds
- Decided: Aug 18, 2010 after 62 days
- Product code: LRK (Device, Anti-Snoring)
- Device class: 2
- Regulation: 21 CFR 872.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K882303 (1989). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050592: Somnomed Mas Rxa, Somnomed, Ltd. (2005) Summary page 1.
- K062333: Laimad, Steven Lamberg, D.D.S (2006) Summary page 2.

## Indications for use
The LambergSleepWell-Smartrusion is used to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Source page: https://510kreport.com/device/K101709
Methodology: https://510kreport.com/methodology